Medical device anchoring

ABSTRACT

Techniques, systems and apparatus for anchoring a therapy delivery device within a body portal are disclosed. An anchoring apparatus may comprise a first part comprising an outer sidewall and opposing grip surfaces. The outer sidewall may extend around a longitudinal axis of the apparatus to define an outer perimeter, at least a portion which may engage a surface of the body portal. A second part may comprise first and second activation members and a slot configured to receive the therapy delivery device. When the therapy delivery device is received in the slot and the second part is moved generally along the longitudinal axis, the first and second activation members may move the opposing grip surfaces toward one another to thereby anchor the therapy delivery device between the opposing grip surfaces.

PRIORITY CLAIM

This application claims priority to United States ProvisionalApplication having the same title, the Ser. No. 62/437,863, and theAttorney Docket No. C00014640.USP1, which was filed on Nov. 15, 2016,and is hereby incorporated by reference in its entirety.

TECHNICAL FIELD

The present disclosure pertains to medical devices and more particularlyto anchoring an elongate portion of the medical device within a bodyportal, for example, a burr hole formed in a skull or cranium of apatient.

SUMMARY

An apparatus for anchoring a therapy delivery device within a bodyportal is disclosed. The therapy delivery device may comprise a medicalelectrical lead, a catheter, a stimulation device, or any other devicethat is adapted to be anchored within a body portal. The apparatus maycomprise a first part and a second part. The first part may comprise anouter sidewall and opposing grip surfaces. In one embodiment, the outersidewall may extend around a longitudinal axis of the apparatus todefine an outer perimeter. The outer sidewall may have ends and the gripsurfaces may extend inward from the ends of the outer sidewall. In oneexample, the grip surfaces are formed by first and second inner sidewallfolding inward from the ends of the outer sidewall.

In one example, at least a portion of the outer sidewall is configuredto engage a surface of the body portal, the opposing grip surfaces mayface toward the longitudinal axis and be configured to receive thetherapy delivery device therebetween.

The apparatus may further comprise a second part comprising a lowersurface, first and second activation members protruding from the lowersurface, and a slot configured to receive the therapy delivery device. Afirst activation member may be located on one side of the slot and thesecond activation member may be located on the other side of the slot.In one embodiment, when the therapy delivery device is received in theslot and the second part is moved generally along the longitudinal axis,the first and second activation members move the opposing grip surfacestoward one another to thereby anchor the therapy delivery device betweenthe opposing grip surfaces.

According to other aspects, at least one of the first and secondactivation members comprises multiple activation members. For instance,multiple activation members (e.g., two such members) may be located oneither side of the slot. In one case, the first part may comprise arespective activation surface for each of the opposing grip surfaces andeach of the first and second activation members may be configured tocome in confronting engagement with a respective one of the activationsurfaces to move the opposing grip surfaces toward one another. In someexamples, each activation surface may extend at an angle relative to therespective grip surface and each of the first and second activationmembers may comprise an angled flange.

In some examples, the first part may comprise incompressible filler andeach of the first and second activation members may be configured todisplace a respective portion of the filler. The incompressible fillermay extend within the outer sidewall, and the first and secondactivation member may comprise a stud configured to displace therespective portion of the filler.

As another example, the apparatus may comprise a base ring configured tobe seated within the body portal, the base ring comprising a rim. Theouter sidewall of the first part may be configured to seat on the rim ofthe base ring. The base ring may be configured to be seated within thebody portal, and the base ring may comprise a sidewall configured toengage the outer sidewall of the first part. The sidewall of the basering may comprise interlocking features and the outer sidewall of thefirst part includes an outer perimeter surface formed with a pluralityof engagement features being equally spaced apart from one anotheraround the outer perimeter of the first part and being configured tomate with the interlocking features of the base ring. The base ring maycomprise at least one locking feature configured to engage a surface ofthe body portal.

The apparatus may, in some cases, comprise a cover that may beconfigured to fit over the first part. The cover may comprise a channelconfigured to receive the therapy delivery device. The channel of thecover may comprise opposing lips configured to grip a portion of thetherapy delivery device. A base ring may be configured to be seated inthe body portal and may comprise an upper rim configured to engage aperimeter edge of the cover.

In another embodiment, a medical system is disclosed that comprises animplantable medical device, a therapy delivery device configured to becoupled to the implantable medical device and an apparatus configured toanchor a portion of the therapy delivery device within a body portal.The implantable medical device may be a stimulation device configured todeliver electrical, ultrasonic, magnetic, optical, or any other type ofstimulation to provide therapy to patients suffering from a variety ofconditions, such as chronic pain, tremor, Parkinson's disease, epilepsy,OCD, depression, dystonia, urinary or fecal incontinence, sexualdysfunction, obesity, or gastroparesis. As examples, electricalstimulation generators are used for chronic delivery of electricalstimulation therapies such as cardiac pacing, neurostimulation, musclestimulation, or the like. Alternatively, the implantable medical devicemay be a pump or other fluid delivery devices. Example fluid deliverydevices may be used for chronic delivery of therapeutic agents, such asdrugs. Typically, such devices provide therapy continuously orperiodically according to parameters contained within a program.

The therapy delivery device may be a device for coupling to theimplantable medical device for delivering therapy to the patient. Forinstance, it may be a medical electrical lead, a device for deliveringoptical stimulation (e.g., and that comprises an optical channel), or acombination thereof. It may be a catheter for delivering a therapeuticagent to the patient. In some examples, the therapy delivery device maybe mechanically coupled to the implantable medical device, and in otherexamples, the therapy delivery device may be functionally but notmechanically coupled to the implantable medical device. For example, thetherapy delivery device may be adapted to send and/or receive wirelesselectrical or other signals from the implantable medical device.

The apparatus of the medical system may comprise a first part comprisingan outer sidewall extending around a longitudinal axis of the apparatusto define an outer perimeter, at least a portion of which is configuredto engage a surface of the body portal. The first part may furthercomprise first and second inner sidewalls extending alongside oneanother within the outer sidewall. The first and second inner sidewallsmay be spaced apart to receive the therapy delivery device therebetween.

The apparatus may further comprise a second part comprising a lowersurface, first and second activation members protruding from the lowersurface, and a slot configured to receive the therapy delivery device.The first activation member may be located on one side of the slot andthe second activation may be located on the other side of the slot.

The second part may be configured to be moved generally along thelongitudinal axis toward the first part to thereby cause the first andsecond activation members to move the first and second inner sidewallstoward one another. The first and second inner sidewalls may therebyanchor the therapy delivery device therebetween when the therapydelivery device is received in the slot of the second part.

According to some examples, each of the first and second inner sidewallsmay further comprise an activation surface facing generally away fromthe longitudinal axis and each of the first and second activationmembers may comprise an angled flange configured to come intoconfronting engagement with a respective one of the activation surfaces.The first part may, in some cases, further comprise filler extendingwithin the outer sidewall, the filler being configured to be displacedto thereby move the first and second inner sidewalls towards oneanother. Each of the first and second activation members may comprise aportion configured to displace the filler of the first part to therebymove the first and second inner sidewalls towards one another. The outersidewall may comprise first and second apertures and the second part mayfurther comprise first and second detent legs, each configured to extendthrough a corresponding one of the first and second apertures to engagea surface of the body portal.

The apparatus of the medical system may further comprise a base ringcomprising a sidewall configured to form a perimeter surface of the bodyportal when the apparatus is fitted within the body portal. The outersidewall of the first part may be configured to contact the sidewall ofthe base ring. The base ring may comprise a lower rim and the outersidewall of the first part may be configured to be seated on the lowerrim. The sidewall of the base ring may comprise at least one lockingfeature that extends away from the longitudinal axis and that isconfigured to engage with a surface of the body portal. The base ringand outer sidewall of the first part may be configured to engage withone another to prevent significant rotation of the first part relativeto the second part around the longitudinal axis of the apparatus.

The apparatus may comprise a cover that is configured to be positionedover an upper surface of the second part. The cover may comprise achannel configured to receive the therapy delivery device. The apparatusmay further comprise a base ring configured to be seated within the bodyportal, the base ring may comprise a rim configured to engage aperimeter edge of the cover. The channel of the cover may compriseopposing lips configured to grip the therapy delivery device.

In another example, an apparatus for anchoring a therapy delivery devicewithin a body portal is disclosed. The apparatus may comprise firstmeans comprising sidewall means, gripping means, and aperture means. Thesidewall means may be for engaging a surface of the body portal, and thegripping means may be for receiving the therapy delivery device and formoving perpendicular to a longitudinal axis. The apparatus may furthercomprise second means comprising slot means, activation means, and legmeans. The slot means may be for receiving the therapy delivery device,the activation means may be for causing the gripping means to movesubstantially perpendicular to the longitudinal axis to grip the therapydelivery device, and the leg means may be for extending through theaperture means to engage a surface of the body portal. The second meansmay be for moving generally along the longitudinal axis towards thefirst means whereby said activation means moves substantiallyperpendicular to the longitudinal axis to grip the therapy deliverydevice and the leg means extends through the aperture means to engage asurface of the body portal.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawings are illustrative of particular embodiments and donot limit the scope of the disclosure. The drawings are not to scale(unless so stated) and are intended for use in conjunction with theexplanations in the following detailed description. Embodiments willhereinafter be described in conjunction with the appended drawingswherein like numerals/letters denote like elements, and:

FIG. 1A is a schematic showing an exemplary stereotactic guidance systemmounted to a patient's cranium;

FIG. 1B is a schematic showing an elongate portion of an implantablemedical device extending through an anchoring mechanism after theguidance system has been removed;

FIG. 1C is a schematic showing an example implantable medical therapysystem;

FIG. 2A is a perspective view of an anchoring apparatus, according tosome embodiments; the apparatus being exploded along a longitudinal axisthereof;

FIGS. 2B-C are perspective views of a first part and a second part,respectively, of the apparatus, according to some embodiments;

FIG. 2D is a schematic cross-section view of the first and second parts,according to some embodiments;

FIG. 3A is a perspective view of the apparatus, according to someembodiments, being fitted in a burr hole of a cranium that is shown inpartial cross-section;

FIG. 3B is a perspective view of a portion of a base ring of theapparatus, according to some embodiments;

FIG. 3C is a perspective view of a cover of the apparatus, according tosome embodiments;

FIGS. 4A-B are perspective views of first and second parts,respectively, which may be employed in lieu of the first and secondparts of FIGS. 2A-D and 3A, in an alternate embodiment of the apparatus;and

FIGS. 4C-D are cross-section views of the apparatus including the firstand second parts of FIGS. 4A-B, according to some embodiments.

DETAILED DESCRIPTION

The following detailed description is exemplary in nature and is notintended to limit the scope, applicability, or configuration ofembodiments disclosed herein. Rather, the description provides practicalexamples, of which those skilled in the art will recognize suitablealternatives. Examples of constructions, materials, dimensions andfabrication processes are provided for select elements and all otherelements employ that which is known by those skilled in the art.Embodiments of anchoring apparatus, disclosed herein, are suitable formounting/fixing in or over a body portal, for example, a cranial burrhole, in order to anchor in place an elongate portion of a medicaldevice, such as an electrical lead or a catheter.

Example anchoring apparatus as disclosed herein may be employed inmedical procedures for treating a variety of neurological conditions.Treating such medical conditions, including but not limited to,Parkinson's disease, essential tremor and dystonia, require access tothe brain, typically through a burr hole formed in the skull or cranium,for the insertion of deep brain stimulating electrodes. Burr holes mayalso be formed for the insertion of a delivery catheter, for example, toprovide drug therapy for similar conditions, or an extraction catheter,for example, a hydrocephalus shunt. Stereotactic apparatus andprocedures, which are known to those skilled in the art, may be employedby surgeons to locate inserted electrodes and/or drug delivery ports intarget regions of the brain. While these examples are illustrative,other body portals may receive therapy delivery devices that may beanchored therein using techniques of the current disclosure.

FIG. 1A is a perspective view of an exemplary stereotactic guidancesystem 100 (e.g. Medtronic Nexdrive® Micropositioning Drive attached tothe Medtronic Nexframe® system) mounted to a patient's skull or cranium13. FIG. 1A illustrates a ring 120 of guidance system 100, which extendsaround a perimeter of a body portal, or burr hole 11 formed in cranium13, supporting a socket assembly 140 to which a micropositioning drive160 is attached. An anchoring mechanism 112 (FIG. 1B; e.g. the MedtronicStimLoc® base) may be mounted around burr hole 11 and fastened tocranium 13, for example, via screws received through holes 106 in a basering of mechanism 112, prior to attaching ring 120 of guidance system100. FIG. 1A further illustrates a therapy delivery device 15 (e.g., anelongate therapy delivery lead or catheter) of a medical system beingheld within drive 160 for advancement through burr hole 11 and into thecranial space for positioning on a target region of the brain.

FIG. 1B illustrates therapy delivery device 15 after guidance system 100has been removed. FIG. 1B further illustrates therapy delivery device 15extending through a slot of mechanism 112 to be anchored betweenmechanism 112 and a cover or a cap that snaps into place thereover (notshown; e.g., the Medtronic StimLoc® base). Those skilled in the artappreciate that a proximal length of therapy delivery device 15, outsidethe cranial space, may be routed, beneath the scalp and subcutaneously,to a therapy generator of the device, for example, an implantablemedical device 28 shown in the schematic of FIG. 1C, which is implantedsubcutaneously in proximity to the patient's clavicle. With furtherreference to FIG. 1C, a distal length 154 of therapy delivery device 15,which has been advanced through burr hole 11, is shown including therapydelivery ports or electrodes 26A, 26B positioned at the target region ofthe brain. In some cases, therapy delivery device 15 may comprise a leadextension. For example, a proximal end of lead extension may be coupledto implantable medical device 28, and a distal end of lead extension maybe coupled to a proximal end of lead. The distal end of lead may bereceived by burr hole 11.

FIG. 1C is a schematic showing an implanted medical therapy system,according to some embodiments of the present disclosure, in whichembodiments of an anchoring apparatus 200, which are described below,may be employed. FIG. 1C illustrates the system including theaforementioned implantable medical device 28, which may comprise astimulation engine to deliver stimulation therapy. FIG. 1C furtherillustrates therapy delivery device 15, which is shown as a therapydelivery lead in this example, coupled thereto via a connector 30 thatterminates the proximal length thereof. FIG. 1C further illustratesdistal length 154 of therapy delivery device 15 extending throughapparatus 200, which is fastened to the patient's cranium 13 around theabove-described burr hole 11. According to embodiments described below,apparatus 200 is configured to secure therapy delivery device 15 inplace so that electrodes 26A, 26B remain positioned at theaforementioned target regions of the patient's brain for stimulationthereof over the course of the system implant.

According to an exemplary embodiment, implantable medical device 28 isconfigured to deliver electrical stimulation therapy to, and/or senseelectrical signals from the patient's brain, via lead electrodes 26A,26B that are mounted to distal length 154 of therapy delivery device 15and electrically coupled to connector 30 via insulated conductors. Thoseskilled in the art are familiar with suitable configurations andconstructions for therapy delivery device 15 and implantable medicaldevice 28. Implantable medical device 28 may include processingcircuitry, memory, signal generation circuitry, sensing circuitry,telemetry circuitry, and a power source. In some cases, implantablemedical device 28 may comprise a pump or other mechanisms for deliveringa therapeutic agent to the patient.

The memory of implantable medical device 28 may includecomputer-readable instructions that are executed by the processingcircuitry, for example, to deliver stimulation therapy to the patient,sense physiological signals of the patient, and/or perform otherfunctions related to treating one or more conditions of the patient. Thetelemetry circuitry may include any suitable hardware, firmware,software or any combination thereof for communicating with anotherdevice, such as a programmer 32. Under the control of the processingcircuitry the telemetry circuitry may receive downlink telemetry fromand send uplink telemetry to programmer 32 with the aid of an antenna,which may be internal and/or external. Programmer 32 may be a handheldcomputing device, computer workstation, or networked computing devicethat includes electronics and other internal components necessary ordesirable for executing the functions associated with the system.

Turning now to a discussion of anchoring mechanisms, FIG. 2A is aperspective view of apparatus 200 (exploded along a longitudinal axis 2thereof) that anchors the aforementioned therapy delivery device 15within a body portal, for example, the aforementioned burr hole 11formed through the patient's cranium 13 (FIGS. 1A-C). FIG. 2Aillustrates apparatus 200 including a first part 210, a second part 220,and a base ring 260, which, according to some embodiments, forms aperimeter surface 265 of the portal/burr hole 11, when ring 260 isfitted therein, so that an outer perimeter of first part 210, forexample, being defined by an outer sidewall 215 thereof, engagesperimeter surface 265 when fitted within the portal/burr hole 11, forexample, being seated on a lower inner rim 262 of ring 260 (better seenin FIG. 3B). Outer sidewall 215 is shown extending around longitudinalaxis 2 from a first end 215A thereof to a second end 215B thereof, andfirst and second ends 215A, 215B being spaced apart from one another toallow an operator to place first part 210 in burr hole 11 and aroundtherapy delivery device 15, which already extends through burr hole 11.FIG. 2A further illustrates first part 210 including first and secondinner sidewalls 211, 212 folding inward from respective first and secondends 215A, 215B of outer sidewall 215, and extending alongside oneanother within outer sidewall 215. With reference to the perspectiveview of first part 210, shown in FIG. 2B, each of inner sidewalls 211,212 includes a grip surface G facing toward axis 2, wherein gripsurfaces G are spaced apart from one another to define a grip zone GZtherebetween. With further reference to FIG. 2A, second part 220 ofapparatus 200 is shown including a disk-like member 223 that has an openslot 223S formed therethrough from an upper surface 223U thereof to alower surface 223L thereof, so that when first and second parts 210, 220are assembled together in apparatus 200, lower surface 223L extendsadjacent to an upper surface 215U of first part outer sidewall 215, andslot 223S is aligned with grip zone GZ of first part 210. According tothe illustrated embodiment, slot 223S and grip zone GZ are each sized toreceive passage of therapy delivery device 15 therethrough, and, whensecond part 220 is moved longitudinally against first part 210,activation members 224 of second part 220, which extend from disk-likemember lower surface 223L, move grip surfaces G of first part innersidewalls 211, 212 toward one another to anchor therapy delivery device15 therebetween. In some cases, this movement of the grip surfaces maybe substantially perpendicular to the longitudinal axis.

With further reference to FIG. 2B, in conjunction with the perspectiveview of second part 220 in FIG. 2C, according to some embodiments, eachinner sidewall 211, 212 of first part 210 includes an activation surface211A, 212A located and oriented for confronting engagement of an angledflange of a corresponding activation member 224 of second part 220therewith, when second part 220 is moved longitudinally (alonglongitudinal axis 2) against first part 210, for example, per arrow Yshown in the schematic cross-section of FIG. 2D. Each activation surface211A, 212A of first part 210 is shown being located opposite thecorresponding grip surface G, facing generally away from axis 2, andextending at an angle relative to the corresponding grip surface G, sothat the confronting engagement of the angled flanges of second partactivation members 224 pushes grip surfaces G together to anchor therapydelivery device 15, for example, as shown in the schematic section ofFIG. 2D. To enhance the anchoring, grip surfaces G may be formed bytexturing and/or overlaying inner sidewalls 211, 212 with a relativelytacky medical grade polymer, such as silicone rubber. Grip surfaces maybe moved generally perpendicular to the longitudinal axis 2.

FIGS. 2A and 2C further illustrate second part 220 of apparatus 200including first and second detent legs 225 that protrude from lowersurface 223L of disk-like member 223, being located opposite one anotheron either side of slot 223S. According to the illustrated embodiment,when second part lower surface 223L extends adjacent to first part uppersurface 215U, and slot 223S is aligned with first part grip zone GZ,each leg 225 extends through a corresponding aperture 205 of first partouter sidewall 215 to engage the perimeter surface of body portal/burrhole 11, for example, by interlocking with lower inner rim 262 of basering 260. The interlock of one of legs 225 with lower inner rim 262 isillustrated for an alternate embodiment of apparatus 200 in FIG. 4D.

FIG. 2A further illustrates apparatus 200 including a cover 230, whichis sized to fit over an entirety of upper surface 223U of second partdisk-like member 223, according to some embodiments, for example, asillustrated in the perspective view of FIG. 3A. FIG. 3A illustratescover 230 engaged with base ring 260, when first part 210 is seated onlower inner rim 262 of ring 260, and second part 220 has been movedagainst first part 210 to anchor therapy delivery device 15 between gripsurfaces G of first part 210, and to interlock detent legs 225 withlower inner rim 262 of ring 260. Thus, the engagement of cover 230 anddetent legs 225 with base ring 260 serve to secure the anchoring oftherapy delivery device 15 between grip surfaces G of first part innersidewalls 211, 212. According to some embodiments, and with reference toFIG. 3B, base ring upper outer rim 261 may include an undercut 261U toengage a perimeter edge 236 of cover 230. FIG. 3A further illustratescover 230 including a channel 235 sized to receive a length of theanchored therapy delivery device 15; and FIG. 3C illustrates an openingof channel 235, which is located at a perimeter edge 236 of cover 230,having opposing lips 203 to grip the length of anchored therapy deliverydevice 15 therebetween. FIG. 3C further illustrates cover 230 includinga removal feature 231, for example, formed by a hole and correspondingcut-out relief formed through cover 230, which facilitates engagement ofa tool with cover 230 to unlock perimeter edge 236 of cover 230 fromundercut 261U of base ring upper outer rim 261.

With further reference to FIG. 2A, in conjunction with FIGS. 3A-B, asidewall of base ring 260, which extends between upper outer rim 261 andlower inner rim 262, includes locking features 266 formed therein. FIGS.2A and 3A-B illustrate locking features 266 extending outward, away fromlongitudinal axis 2, and being configured to engage with cranium 13,within a perimeter of burr hole 11, when upper outer rim 216 rests on anouter surface of cranium 13, which is shown in partial cross-section inFIG. 3A. Although FIG. 2A shows base ring 260 including a slot,alternate embodiments need not include the slot. With further referenceto FIGS. 2A-B, an outer perimeter surface of first part outer sidewall215 is formed with a plurality of uniform engagement features, forexample, outward protruding ridges, which are equally spaced apart fromone another around the perimeter of first part 210, and are configuredto mate with uniform interlocking features, for example, inwardprotruding ridges, formed along perimeter surface 265 of base ring 260(FIG. 3B). This mating of first part outer sidewall 215 with perimetersurface 265 of base ring 260 can prevent significant rotation of firstpart 210 relative to base ring 260, around longitudinal axis 2, and anoperator can seat first part 210 in a plurality of orientations aboutlongitudinal axis 2 of apparatus 200 (e.g., in 5 degree increments), forexample, to accommodate various trajectories of implanted therapydelivery device 15 through burr hole 11.

With further reference to FIG. 3A, in some embodiments, apparatus 200 isadapted to sit entirely, or substantially entirely, within burr hole 11,without extending above the surface of the portion of cranium 13surrounding burr hole 11, thereby minimizing a profile of apparatus 200.Furthermore, a longitudinal extent of grip surfaces may approach athickness of cranium 13 (e.g., about 5 mm) at burr hole 11, for example,greater than 50% of the cranium thickness, to maximize a gripping forcebetween grip surfaces G.

According to some alternate embodiments, base ring 260 is not includedin apparatus 200 so that outer sidewall 215 of first part 210 interfacesdirectly with cranium 13 when first part 210 is inserted within burrhole 11. FIG. 2B illustrates first part 210 including optional mountingmembers 216 extending from upper surface 215U of outer sidewall 215 torest on a surface of cranium 13 surrounding burr hole 11, when firstpart 210 is inserted therein. Each mounting member 216 is shownincluding the aforementioned screw hole 106 to receive a screw forfastening first part 210 to the cranium, and mounting members 216 may berelatively flexible to conform to a curvature of the cranium when firstpart 210 is fastened.

According to exemplary embodiments of apparatus 200, cover 230, firstpart 210, second part 220, and base ring 260 may each be formed from anysuitably elastic and rigid medical grade material, either metal (e.g.,titanium or stainless steel), or plastic, (e.g., polyether etherketone—PEEK, or polysulfone), or a combination thereof. As was mentionedabove, grip surfaces G may be formed in part by an overlay of medicalgrade silicone rubber on inner sidewalls 211, 212.

FIGS. 4A-B are perspective views of first and second parts 410, 420,respectively, which may be included in anchoring apparatus 200, in lieuof the above described first and second parts 210, 220, according tosome alternate embodiments. FIG. 4A illustrates first part 410 includingan outer sidewall 415, and first and second inner sidewalls 411, 412,wherein inner sidewalls 411, 412 fold inward from respective first andsecond ends 415A, 415B of outer sidewall 415, and extend alongside oneanother within outer sidewall 415. Like inner sidewalls 211, 212 offirst part 210, each inner sidewall 411, 412 of first part 410 includesa grip surface G facing toward axis 2, wherein grip surfaces G arespaced apart from one another to define a grip zone GZ therebetween. Toenhance the anchoring, grip surfaces G may be formed by texturing and/oroverlaying inner sidewalls 411, 412 with a relatively tacky medicalgrade polymer, such as silicone rubber. FIG. 4A further illustratesfirst part 410 including a relatively soft and incompressible filler 414(e.g., having a durometer <5 on a shore A scale) extending within outersidewall 415 and alongside inner sidewalls 411, 412, on either side ofgrip zone GZ. Filler 414 may be a medical grade silicone rubber, andouter and inner sidewalls 415, 411, 412 may be formed from one or moreof any of the aforementioned suitably elastic and rigid medical gradematerials. FIG. 4B illustrates second part 420 including a disk-likemember 423 and activation members 424 that protrude from a lower surface423L thereof, wherein each member 424 may be formed as a rounded stud.An open slot 423S is shown being formed through disk-like member 423from an upper surface 423U thereof to lower surface 423L thereof,wherein activation members 424 are located on either side of slit 423S.FIG. 4B further illustrates second part 420 including detent legs 225like second part 220, and with reference back to FIG. 4A, first partsidewall 415 includes apertures 405 formed therethrough, wherein eachaperture 405 is sized to allow an extension of a corresponding detentleg 225 therethrough. In FIG. 4A, a barrier wall 44 is shown extendingbetween each aperture 405 and filler 414, on either side of innersidewalls 411, 412, to contain filler 414 in first part 410.

According to the illustrated example, when first and second parts 410,420 are assembled together in apparatus 200 (in lieu of parts 210, 220),lower surface 423L of second part disk-like member 423 extends adjacentto an upper surface 415U of first part outer sidewall 415, and slot 423Sis aligned with grip zone GZ, for example, as illustrated in thecross-section views of FIGS. 4C-D. FIG. 4C shows outer sidewall 415 offirst part 410 seated on inner lower rim 262 of base ring 260, and eachdetent leg 225 extending through the corresponding aperture 405, so thateach activation members 424 of second part 420 is positioned just abovefirst part filler 414. With reference back to FIG. 4A, note that anouter perimeter surface of outer sidewall 415 of first part 410 may beconfigured in a manner similar to first part 210 so that the outerperimeter surface of outer sidewall 415 will engage with perimetersurface 265 formed by ring 260, as described above for first part 210.FIG. 4D shows second part 420 having been moved longitudinally (alonglongitudinal axis 2) against first part 410, per arrow Y, so that eachdetent leg 225 interlocks with lower inner rim 262 of base ring 260, andactivation members 424 are in confronting engagement with filler 414.According to the illustrated embodiment, the confronting engagementdisplaces filler 414 to move grip surfaces G of inner sidewalls 411, 412toward one another so that grip zone GZ of first part 410 anchorstherapy delivery device 15. Although not shown, cover 230 may be fittedover an entirety of upper surface 423U of second part disk-like member423, being engaged with base ring 260 as described above in conjunctionwith FIGS. 3A-C, so that the length of the anchored therapy deliverydevice 15 extends through cover channel 235. FIGS. 4B-D furtherillustrate upper surface 423U having a smoothed and uniform contouraround slot 423S to provide strain relief for the length of anchoredtherapy delivery device 15. Such a contour may also be employed insecond part 210.

The foregoing detailed description sets forth exemplary embodiments, ofwhich various features may be mixed and matched to form a number ofaddition embodiments that are not outside the scope of the instantdisclosure. Furthermore, it may be appreciated that variousmodifications and changes can be made without departing from the scopeand spirit of the disclosure as set forth in the appended claims.

What is claimed is:
 1. An apparatus for anchoring a therapy deliverydevice within a body portal, comprising: a first part comprising anouter sidewall and opposing grip surfaces, the outer sidewall extendingaround a longitudinal axis of the apparatus to define an outerperimeter, at least a portion of the outer sidewall being configured toengage a surface of the body portal, the opposing grip surfaces facingtoward the longitudinal axis and being configured to receive the therapydelivery device therebetween; and a second part comprising a lowersurface, first and second activation members protruding from the lowersurface, and a slot configured to receive the therapy delivery device,wherein the first activation member is located on one side of the slotand the second activation member is located on the other side of theslot; and wherein, when the therapy delivery device is received in theslot and the second part is moved generally along the longitudinal axis,the first and second activation members move the opposing grip surfacestoward one another to thereby anchor the therapy delivery device betweenthe opposing grip surfaces.
 2. The apparatus of claim 1, wherein atleast one of the first and second activation members comprises multipleactivation members.
 3. The apparatus of claim 1, wherein the first partfurther comprises, a respective activation surface for each of theopposing grip surfaces, and wherein each of the first and secondactivation members is configured to come in confronting engagement witha respective one of the activation surfaces to move the opposing gripsurfaces toward one another.
 4. The apparatus of claim 3, wherein eachactivation surface extends at an angle relative to the respective gripsurface and each of the first and second activation members comprises anangled flange.
 5. The apparatus of claim 1, wherein the first partfurther comprises incompressible filler and wherein each of the firstand second activation members is configured to displace a respectiveportion of the filler.
 6. The apparatus of claim 5, wherein theincompressible filler extends within the outer sidewall, and the firstand second activation member comprises a stud configured to displace therespective portion of the filler.
 7. The apparatus of claim 1, furthercomprising a base ring configured to be seated within the body portal,the base ring comprising a rim, and wherein the outer sidewall of thefirst part is configured to seat on the rim of the base ring.
 8. Theapparatus of claim 1, further comprising a base ring configured to beseated within the body portal, the base ring comprising a sidewallconfigured to engage the outer sidewall of the first part.
 9. Theapparatus of claim 8, wherein the base ring comprises at least onelocking feature configured to engage a surface of the body portal. 10.The apparatus of claim 1, further comprising a cover configured to fitover the first part, the cover including a channel configured to receivethe therapy delivery device.
 11. The apparatus of claim 10, furthercomprising a base ring configured to be seated in the body portal, thebase ring having an upper rim configured to engage a perimeter edge ofthe cover.
 12. The apparatus of claim 10, wherein the channel of thecover comprises opposing lips configured to grip a portion of thetherapy delivery device.
 13. The apparatus of claim 8, wherein thesidewall of the base ring comprises interlocking features and the outersidewall of the first part comprises an outer perimeter surface formedwith a plurality of engagement features being equally spaced apart fromone another around the outer perimeter of the first part and beingconfigured to mate with the interlocking features of the base ring. 14.A medical system comprising: an implantable medical device; a therapydelivery device configured to be coupled to the implantable medicaldevice; and an apparatus configured to anchor a portion of the therapydelivery device within a body portal comprising: a first part comprisingan outer sidewall extending around a longitudinal axis of the apparatusto define an outer perimeter, at least a portion of which is configuredto engage a surface of the body portal, the first part furthercomprising first and second inner sidewalls extending alongside oneanother within the outer sidewall, the first and second inner sidewallsbeing spaced apart to receive the therapy delivery device therebetween;and a second part comprising a lower surface, first and secondactivation members protruding from the lower surface, and a slotconfigured to receive the therapy delivery device, wherein the firstactivation member is located on one side of the slot and the secondactivation is located on the other side of the slot; and wherein thesecond part is configured to be moved generally along the longitudinalaxis toward the first part to thereby cause the first and secondactivation members to move the first and second inner sidewalls towardone another, the first and second inner sidewalls thereby anchoring thetherapy delivery device therebetween when the therapy delivery device isreceived in the slot of the second part.
 15. The medical system of claim14, wherein each of the first and second inner sidewalls furthercomprises an activation surface facing generally away from thelongitudinal axis and each of the first and second activation memberscomprises an angled flange configured to come into confrontingengagement with a respective one of the activation surfaces.
 16. Themedical system of claim 14, wherein the first part further comprisesfiller extending within the outer sidewall, the filler being configuredto be displaced to thereby move the first and second inner sidewallstowards one another.
 17. The medical system of claim 16, wherein each ofthe first and second activation members comprises a portion configuredto displace the filler of the first part to thereby move the first andsecond inner sidewalls towards one another.
 18. The medical system ofclaim 14, wherein the outer sidewall comprises first and secondapertures and wherein the second part further comprises first and seconddetent legs, each configured to extend through a corresponding one ofthe first and second apertures to engage a surface of the body portal.19. The medical system of claim 14, wherein the apparatus furthercomprises a base ring comprising a sidewall configured to form aperimeter surface of the body portal when the apparatus is fitted withinthe body portal, and wherein the outer sidewall of the first part isconfigured to contact the sidewall of the base ring.
 20. The medicalsystem of claim 19, wherein the base ring comprises a lower rim andwherein the outer sidewall of the first part is configured to be seatedon the lower rim.
 21. The medical system of claim 19, wherein thesidewall of the base ring comprises at least one locking feature thatextends away from the longitudinal axis, and wherein the at least onelocking feature is configured to engage with a surface of the bodyportal.
 22. The medical system of claim 19, wherein the base ring andouter sidewall of the first part are configured to engage with oneanother to prevent significant rotation of the first part relative tothe second part around the longitudinal axis of the apparatus.
 23. Themedical system of claim 14, wherein the apparatus further comprises acover being configured to be positioned over an upper surface of thesecond part, the cover comprising a channel configured to receive thetherapy delivery device.
 24. The medical system of claim 23, wherein theapparatus further comprises a base ring configured to be seated withinthe body portal, the base ring comprising an upper rim configured toengage a perimeter edge of the cover.
 25. The medical system of claim23, wherein the channel of the cover comprises opposing lips configuredto grip the therapy delivery device.
 26. An apparatus for anchoring atherapy delivery device within a body portal, comprising: first meanscomprising sidewall means, gripping means, and aperture means, thesidewall means for engaging a surface of the body portal, and thegripping means for receiving the therapy delivery device and for movingperpendicular to a longitudinal axis; and second means comprising slotmeans, activation means, and leg means, the slot means for receiving thetherapy delivery device, the activation means for causing the grippingmeans to move substantially perpendicular to the longitudinal axis togrip the therapy delivery device, and the leg means for extendingthrough the aperture means to engage a surface of the body portal; thesecond means for moving generally along the longitudinal axis towardsthe first means whereby said activation means moves substantiallyperpendicular to the longitudinal axis to grip the therapy deliverydevice and the leg means extends through the aperture means to engage asurface of the body portal.